NCT01943370

Brief Summary

Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus surgery. However, the ideal timing and quantity of irrigation in the early post-operative period remains unknown. Proposed benefits of early, large volume irrigation include removal and softening of crusts, resulting in improved mucociliary clearance. The potential benefit of early large volume saline irrigation on post-operative day three to ease or reduce the need for early post-operative debridement has not been studied.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

September 6, 2013

Last Update Submit

October 11, 2018

Conditions

Chronic Rhinosinusitis

Keywords

endoscopic sinus surgerypost-operative irrigationpaindebridement

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain and discomfort during early post-operative debridement on post-operative day 10

    Early post-operative (Day 10)

Secondary Outcomes (2)

  • Endoscopic appearance

    Early (post-operative day 10)

  • Late endoscopic appearance at 6 months

    6 months

Study Arms (2)

Early saline irrigation

EXPERIMENTAL

Initiation of early saline irrigation

Other: Early saline irrigation

Late or Routine Saline Irrigation

ACTIVE COMPARATOR

Routine initiation of saline irrigation

Other: Early saline irrigationOther: Routine Irrigation

Interventions

Early saline irrigationOTHER

Initiation of post-operative saline irrigation earlier during the post-operative course

Early saline irrigationLate or Routine Saline Irrigation
Routine IrrigationOTHER

Routine initiation of saline irrigation

Late or Routine Saline Irrigation

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Diagnosis of CRS with or without polyposis
  • Undergoing bilateral endoscopic sinus surgery
  • Availability of pre-operative CT paranasal sinuses

You may not qualify if:

  • Patients with diagnosis of:
  • Primary ciliary dyskinesia
  • Immunodeficiency
  • Cystic fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 17, 2013

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

October 15, 2018

Record last verified: 2018-10